Dietary Supplement Concerns in 2012

Although there is no safety data generally for use in conventional foods, animal studies have raised red flags on potential adverse effects for some dietary supplements.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) (P.L. No. 103-417), Congress said that the federal government should not excessively regulate dietary supplements and that supplements should not be regulated in the same manner as medications.” Since the passage of the DSHEA, the number of dietary supplements has surged from 4,000 to an estimated 50,000 to 75,000. The FDA does not know exactly how many supplements are being sold, however, because companies do not need to register individual products. Companies only need to submit a notice of intent if desired.

In late December of 2011, Senators Orrin Hatch and Tom Harkin wrote the FDA requesting that the agency reconsider its draft guidance on new dietary ingredients (NDI), titled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” and expressing concern that the FDA failed to clarify what constituted an NDI.

Depending on the interests at stake, other lawmakers are pushing for tighter regulation of vitamins, herbs, weight-loss products and other dietary supplements. For instance, the Dietary Supplement Labeling Act of 2011 introduced by Senator Dick Durbin would increase labeling requirements and require companies to register their products, citing health risks from products that blur the line dividing supplements from food and beverages.

The supplement industry is not in favor of the prospect of stronger FDA oversight and additional rules governing the use of new dietary ingredients. The real problem the industry notes is that the FDA is not enforcing regulations already on the books. Additional requirements would raise the cost of supplements, burden manufacturers, limit availability and infringe on a consumer’s “personal freedom.”

Yet, there are questions as to whether consumers have enough reliable information to make smart decisions about the products purchased. Unlike drugs, which need pre-market approval, dietary supplements are not approved by the FDA for safety or efficacy before they hit store shelves. Dietary supplement labels must be truthful, but the FDA does not review them in advance. The FDA can go after a company only if it demonstrate that a supplement is dangerous. A 2009 report by the Government Accountability Office that recommended increasing the FDA’s power over supplements found that foods could “be marketed as dietary supplements to circumvent the (more stringent) safety standards required for food additives.”

Additionally, beyond the reliability of labels on dietary supplements, the GAO found that consumers are generally uneducated about supplements. More than half of U.S. adults take dietary supplements and the majority mistakenly believe that a government agency approves such products, the report said.

How would the FDA’s stance as stated in the NDI draft guidance infringe on consumers’ ability to select supplements based on their individual health needs? It seems, when appropriate, that manufacturers will have to provide evidence of an NDI’s safety, and if evidence is not provided that the NDI is safe for consumers, the NDI cannot be sold to consumers.

But opponents of the draft guidance have countered that too much burden is placed on dietary supplement manufacturers and could open the door to the FDA determining which supplements are safe enough to allow on the market, contrary to congressional intent. Senators Hatch and Harkin stressed this point in their letter to the FDA Commissioner.